Galafold Eiropas Savienība - latviešu - EMA (European Medicines Agency)

galafold

amicus therapeutics europe limited - migalastat hydrochloride - fabriku slimība - migalastat - galafold ir norādīts par ilgtermiņa attieksmi pret pieaugušajiem un pusaudžiem vecumā no 16 gadiem un vecāki ar apstiprināto diagnostiku fabry slimības (α-galactosidase trūkumu) un kuriem ir grozāmi mutāciju.

Imatinib Actavis Eiropas Savienība - latviešu - EMA (European Medicines Agency)

imatinib actavis

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. spēkā imatinib par rezultātiem, kaulu smadzeņu transplantācija nav noteikta. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. pieredze ar imatinib pacientiem ar mds/mpd, kas saistīti ar pdgfr gēnu re-kārtība ir ļoti ierobežota. nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību.

Porcilis PCV ID Eiropas Savienība - latviešu - EMA (European Medicines Agency)

porcilis pcv id

intervet international b.v. - cūku cirkovīrusa 2. tipa orf2 subvienības antigēns - immunologicals for suidae, inactivated viral vaccines - cūkas - for the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by pcv2 infection.  to reduce loss of daily weight gain and mortality associated with pcv2 infection.

Myozyme Eiropas Savienība - latviešu - EMA (European Medicines Agency)

myozyme

sanofi b.v. - alglucosidase alfa - glikogēna uzglabāšanas slimības ii tipa - citas gremošanas trakta un metabolisma produkti, - myozyme ir indicēts ilgstošai enzīmu aizstājterapijai (ert) pacientiem ar apstiprinātu pompe slimības (skābes-α-glikozidāzes deficīta) diagnozi. pacientiem ar vēlīniem pompe slimība iedarbīgumu ir ierobežots.

Replagal Eiropas Savienība - latviešu - EMA (European Medicines Agency)

replagal

takeda pharmaceuticals international ag ireland branch - agalsidase alfa - fabriku slimība - citas gremošanas trakta un metabolisma produkti, - replagal indicēts ilgtermiņa fermentu aizvietošanas terapiju pacientiem ar apstiprināto diagnostiku fabry slimības (α-galactosidase-trūkumu).